Ethics in Research Flashcards
Ethics in research
Researchers have a responsibility for honesty and integrity in all phases of research and to perform clinical research that is meaningful.
Investigators must be competent and adhere to strict ethical guidelines. Researchers should minimize personal bias during research. It is NOT ethical to involve patients in a study when the study poses a potential negative impact or high risk of danger or injury to the patient.
How can evidence be used?
Evidence can be used to bring about change for one patient, across a system, or for the profession.
Research with human subjects requires adherence to 3 basic principles:
- Autonomy
- Beneficence
- Justice
What is autonomy?
Personal autonomy is the capacity of the individual to make decisions affecting their lives and to act on those decisions.
Children and patients with cognitive difficulties may be unable to understand their involvement in the research. Therefore, it is the researchers’ responsibility to make sure these individuals have a surrogate decision maker and to make sure that they have the ability to make a reasonable and informed decision about the research.
What is beneficence?
Beneficence is basically the obligation to attend to the well-being of individuals.
All who engage in clinical research are bound to maximize possible benefits and minimize possible harm.
The balance between risks and benefits must be weighed as part of the decision to go forward with a specific project. Risks may be physical, economic, social, or psychological.
What is justice?
The selection of research subjects should not be discriminatory on some irrelevant criterion, but based on reasons directly related to the problem being studied.
Justice refers to the fairness in the research process or the equal distribution of benefits and burdens.
The selection of subjects for a given research study must be fair and should be gathered from a specific population of subjects that would benefit from the research findings.
Abuse in research
In the United States many horrible and unconscionable studies have been identified over the years. These and other abuses in research across the world became a guiding force to establish formal guidelines explaining the rights of research subjects and explaining the obligations of professional investigators. It became increasing clear that official guidelines had to be developed to ensure the rights and dignity of human research subjects.
Examples of abuse in research
In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for African Americans. It was called the “Tuskegee Study of Untreated Syphilis in the Negro Male.”
The study initially involved 600 black men – 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients’ informed consent. Researchers told the men they were being treated for “bad blood.” In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.
What went wrong in the Tuskegee study?
The men were never given adequate treatment for their disease. Even when penicillin became the drug of choice for syphilis in 1947, researchers did not offer it to the subjects. The advisory panel found nothing to show that subjects were ever given the choice of quitting the study, even when this new, highly effective treatment became widely used.
How did the Tuskegee study end?
In October 1972, the Tuskegee Study was labeled “ethically unjustified” and the study officially ended in November 1972.
In 1973, class-action lawsuit was filed on behalf of the study participants and their families. In 1974, a $10 million out-of-court settlement was reached.
The advisory panel concluded that the Tuskegee Study was “ethically unjustified”–the knowledge gained was sparse when compared with the risks the study posed for its subjects. In October 1972, the panel advised stopping the study at once. A month later, the Assistant Secretary for Health and Scientific Affairs announced the end of the Tuskegee Study.
What is the Tuskegee Health Benefit Program?
The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, wives, widows and offspring were added to the program. In 1995, the program was expanded to include health as well as medical benefits.
The Centers for Disease Control and Prevention was given responsibility for the program, where it remains today in theNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
The last study participant died in January 2004.
The last widow receiving THBP benefits died in January 2009. There are 12 offspring currently receiving medical and health benefits.
What are the Nazi experiments?
The experiments were conducted in concentration camps, and in most cases resulted in death, disfigurement, or permanent disability.
Disturbing experiments included:
- genetically manipulate twins
- bone, muscle, and nerve transplantation
- exposure to diseases and chemical gasses
- sterilization
After the war, these crimes were tried as part of the Nuremberg Trial and ultimately led to the development of the Nuremberg Code of medical ethics.
What is the Nuremberg Code of 1949?
Emphasized that every individual should voluntarily consent to participate as a research subject and addressed the competence of the investigator stating “the research should be conducted only by scientifically qualified persons” - Consent should only be given after a subject has sufficient knowledge of the purposes, procedures, and risks involved in research experiments.
What is the Declaration of Helsinki?
The World Medical Association originally adopted the Declaration of Helsinki in 1964.
Addressed the concept of independent review of research protocols by a committee of individuals who are not associated with the proposed project.
These principles have been incorporated into the U.S. Department of Health and Human Services Rules and Regulations.
This declaration declares that reports of research that has not been conducted according to stated principles should not be accepted for publication.
What is the National Research Act of 1974?
The National Research Act of 1974 was developed to ensure the protection and rights of human subjects in research and are now considered “standard” throughout the United States.
This Act demands that research must have a fully developed research proposal that identifies the problem or question to be studied and provides rationale for the importance of the study. The research design must be clearly stated and deemed appropriate to answer the research question. Informed consent MUST be obtained from individuals or from their legally authorized representatives.
